Here are the most frequently asked questions (FAQ) about the ISABELA1 study,
a clinical trial for idiopathic pulmonary fibrosis (IPF).
What does the study look like?
The ISABELA clinical study program entails two identical designed studies: ISABELA 1 and ISABELA 2. The studies are intended to confirm each other’s results.
The studies consist of an up to four-week screening period (to see whether patients qualify for participation), a treatment period of at least 52 weeks, and a follow-up period of four weeks. At least 13 visits to the site are foreseen in these periods. Participant health will be monitored throughout the studies.
Where are the study centers located?
In the Study Center Locator, you will find active study centers in your region. Please make sure to check back at a later date in case you don’t see any active sites in your region yet. We do not know beforehand exactly when a center will be activated, but the Study Center Locator will be updated regularly with the most current information.
How many participants are expected?
There will be 1,500 participants in total, or 750 in each of the two studies.
Who is eligible to participate in the study?
Patients with an established diagnosis of IPF in the last five years may be able to participate, whether or not they are taking pirfenidone, nintedanib, or neither/no IPF treatment. Patients need to be 40 years of age or older and should be able to come to the hospital for visits. A full check of all eligibility criteria will be performed by the study center.
Will participants be allowed to stay on their pirfenidone or nintedanib treatment?
Can I participate in the study without being on an approved IPF treatment?
Does it cost money to participate?
What will participants receive during the study?
All participants will receive:
- Study medication or placebo
- Study-related medical care
- Reimbursement for study-related expenses
What is GLPG1690, and how does it work?
GLPG1690 is an experimental drug that can be taken in tablet form by mouth. “Experimental” means that the study drug is currently under investigation and is not yet approved for any illness in any country by the Ministry of Health or other governmental institutions.
It has been described that patients with IPF have increased levels of autotaxin. It is being investigated whether this drug can, by decreasing the activity of autotaxin, safely inhibit increased autotaxin levels in the lungs that occur in people with IPF and therefore affect the progression of the disease.
Will there be a chance of receiving a placebo?
Yes, there will be a one in three (1 in 3) chance for participants to receive a placebo in addition to their standard IPF care/treatment. Two thirds (2/3) of patients will receive GLPG1690 in addition to their standard IPF care/treatment—half of them on the 200 mg dose and the other half on the 600 mg dose—for the duration of the study.
How long will participants receive the study drug?
Participants will receive the study drug for at least 52 weeks. Participants will remain on the study drug or placebo until the last participant in their respective study has completed 52 weeks. Therefore, some participants will continue in the study for a substantial period of time beyond 52 weeks.
How long will participants be in the study?
Participants will be in the study for an up to four-week screening period, a study treatment period of at least 52 weeks (see above question for more details), and a follow-up period of four weeks.
How long will the study last?
This study will continue until the last participant has reached week 52 in the study.
What is the primary goal of the study?
The primary goal is to establish the safety and effectiveness of GLPG1690 as the treatment of IPF on top of standard of care. The primary endpoint is the rate of decline of Forced Vital Capacity (FVC, in mL) until week 52, which indicates lung function decline, assessed by spirometry.
What else will be measured?
In addition to safety, tolerability, and efficacy, impact on quality of life will also be measured.
What will happen during the study?
During the study, participants are requested to:
- Take the study medication as instructed by the study doctor
- Attend all scheduled study visits
- Answer questions about their health
- Complete lung function tests
- Provide urine and blood samples at study visits
- Follow all instructions from the study staff